India Risk Classification for Personal Protective Equipment
CDSCO PPE Medical Device Classification Guide: India Rules
Introduction: Personal Protective Equipment Classification in India
Personal Protective Equipment (PPE) acts as an important tool for the protection of healthcare workers, patients, and even the general population against different health risks. Under the Medical Device Rules 2017 in India, PPEs are classified according to different risk levels in order to meet the safety requirements.
In line with its ongoing effort to improve the CDSCO medical device classification in India, the Central Drugs Standard Control Organization (CDSCO) has announced the latest notification regarding the classification of some Personal Protective Equipment classification in India.
India is Updating Existing Risk Based Classifications for Personal Protective Equipment
Based on the latest notification MED-16014(12)/1/2024-eOffice dated January 6th, 2025, there are a total of 21 such devices that fall into this category and are now categorized under Class A (Self Notified) instead of being in Class A. This is beneficial in ensuring compliance among the least risky devices and follows the Updated CDSCO medical device rules in India. These rules have a significant contribution to ensure medical device compliance in India.
There are changes in the classification of the medical device category by CDSCO as well, with changes made in the risk level of the devices in line with the advancement of medical technology and regulatory requirements.
Table: CDSCO Personal Protective Equipments Classification in India
Classification of Personal Protective Equipment in India in accordance with CDSCO medical device classification in India is given in the following table. The recently re-classified products from Class A to Class A (Self Notified) are given in dark grey.
S.No. | Device name as per Medical Device Rules 2017 in India | Intended Use | RiskClass |
|---|---|---|---|
1 | Biosanitizer for Medical devices | Intended for surface disinfection of medical devices, nonporous hard surfaces, medical equipment, units, as well as in depth cleaning of small surfaces. | B |
2 | Latex surgical glove | Natural rubber based gloves intended to protect the patient and wearer from cross infection when used in medical or dental surgery. | B |
3 | Non latex surgical glove | Synthetic material glove intended to protect the patient and wearer from cross infection when used in medical or dental surgery. | B |
4 | Non latex medical examination glove | Gloves made of synthetic materials, and used to protect the patient and users from cross infection during examination,check up, treatment and handling of contaminated medical materials except for surgery. | A |
5 | Latex medical examination glove | Natural rubber gloves are used to protect the patient and users from cross infection during examination, check up, treatment and handling of contaminated medical materials except for surgery. | A |
6 | Surgical gown (Sterile) | A sterile garment made of natural and/or synthetic materials intended for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | B |
7 | Surgical gown (Non Sterile) | A non sterile garment made of natural and/or synthetic materials intended for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | A |
8 | Isolation Gown (Sterile) | A sterile garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect themselves from a contagious agent which has infected the patient. | B |
9 | Isolation Gown (Non Sterile) | A non sterile garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect themselves from a contagious agent which has infected the patient. | A |
10 | Personal Protective Equipment | PPE kit used to act as a barrier between infectious materials such as viral and bacterial contaminants and skin,mouth, nose, or eyes. It refers to protective clothing,helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. | B |
11 | Surgical Drape & Drape Accessories | A surgical drape & drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial & other contamination. | B |
12 | Protective garment for Incontinence | Intended to protect an incontinent patient’s garment from the patient's excreta. | A (Self Notified) |
13 | Face shield | Intended to protect the wearer’s entire face (or part of it)from hazards such as chemical splashes (in laboratories or in industry), or potentially infectious materials (in medical and laboratory environments). | A (Self Notified) |
14 | Radiation protection gloves | A personal protection device that completely protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. | A (Self Notified) |
15 | Partial hand radiation protector | A flat pad with straps or partial gloves that protect part of hands and fingers from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. | A (Self Notified) |
16 | Radiation protection apron | A standard length or half length apron to protect the patient,the operator, and other personnel from radiation exposure during a medical or dental procedure. Some have a fixed or removable collar to protect the neck and thyroid. | A (Self Notified) |
17 | Radiation protection mitten | A personal protection device that protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. The mittens are also called mitts, and protect the thumb and other fingers individually or together. | A (Self Notified) |
18 | Radiation protection goggles | A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical/dental procedures for diagnosis and treatment. | A (Self Notified) |
19 | Radiation face protector | A transparent or opaque personal protection device that protects the face and eyes of medical personnel and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. | A (Self Notified) |
20 | Operator radiation protection spectacles | A personal protection device that protects the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment.The device comes in non correction(non prescription) glasses and visual acuity correction(prescription) glasses. | A (Self Notified) |
21 | Gonadal radiation protector | A personal protection device that attenuates unnecessary radiation exposure in diagnostic, medical or dental procedures, and shields the gonad of the patient and the operator. | A (Self Notified) |
22 | Radiation protection blanket | A personal protection device that protects specific body parts of the patient, operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. | A (Self Notified) |
23 | Radiation protection collar | A personal protection device that protects the neck or thyroid of the patient, the operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. | A (Self Notified) |
24 | Radiation protection cap | A personal protection device that protects the head of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical procedures for diagnosis and treatment. | A (Self Notified) |
25 | Mobile radiation protection barrier | A stand alone, movable barrier that protects the operator etc.from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures. | A (Self Notified) |
26 | chemotherapy spill clean up kit | Designed to safely clean and dispose of Chemotherapy drugspills. | A (Self Notified) |
27 | Medical/Cadaver Body Bags | Intended for transporting a human corpse without any spread of biohazard/infectious agent. | A (Self Notified) |
28 | Patient Gown | A garment made of natural and/or synthetic materials (e.g.,paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor’s office). A patient gown is usually short sleeved and may be closed by ties at the back/side of the garment. | A (Self Notified) |
29 | Professional Examination Gown | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. | A (Self Notified) |
30 | Surgical Helmet | Intended to protect healthcare workers from contaminants &debris on head. | A (Self Notified) |
31 | Surgical Cap | Intended to protect the face of the patient & the operating room personnel from the transfer of micro organisms, body fluids and particulate material. | A (Self Notified) |
32 | Operating Room Shoes Cover | Intended to be worn by operating room personnel during surgical procedures to protect foot of both the surgicalpatient & the operating room personnel from transfer ofmicro organisms, body fluids, and particulate material. | A (Self Notified) |
Conclusion: Medical Device Compliance in India for Personal Protective Equipment
The present article is based on notifications 29/MiscJ03/2020-DC (186) and MED-16014(12)/1/2024-eOffice, which provide the classification of Personal Protective Equipment regulations in India. The CDSCO medical device classification in India follows an approach that takes into consideration the intended purpose of use, risk profile, and other related parameters of the devices.
The classification process is not static and is updated from time to time depending on the changes in the international standards. If you need professional assistance in registering your medical device in India, Morulaa can help. Get expert consultancy services from Morulaa and learn how to register your device effectively in India by contacting admin@morulaa.com.
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